Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
fondaparinux sodium
Mylan IRE Healthcare Limited
B01AX05
fondaparinux sodium
Antithrombotic agents
Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injectionPrevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery.Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery.Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease.Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.2.5-mg/0.5-ml solution for injectionTreatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated.infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injectionTreatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Revision: 35
Authorised
2002-03-20
84 B. PACKAGE LEAFLET 85 PACKAGE LEAFLET: INFORMATION FOR THE USER ARIXTRA 1.5 MG/0.3 ML SOLUTION FOR INJECTION fondaparinux sodium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT ARIXTRA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARIXTRA 3. HOW TO USE ARIXTRA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE ARIXTRA 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT ARIXTRA IS AND WHAT IT IS USED FOR ARIXTRA IS A MEDICINE THAT HELPS PREVENT BLOOD CLOTS FROM FORMING IN THE BLOOD VESSELS ( _an _ _antithrombotic agent_ ). Arixtra contains a synthetic substance called fondaparinux sodium. This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots ( _thromboses_ ) from forming in the blood vessels. ARIXTRA IS USED TO: • prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness _. _ • treat blood clots in blood vessels that are near the surface of the skin of the legs ( _superficial-vein _ _thrombosis_ ). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ARIXTRA DO NOT USE ARIXTRA: • IF YOU ARE ALLERGIC to fondaparinux sodium or to any of the other ingredients of this medicine (listed in section 6) • IF YOU ARE BLEEDING EXCESSIVELY • IF YOU HAVE A BACTERIAL HEART INFECTION • IF YOU HAVE VERY SEVERE KIDNEY DISE Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium. Excipient(s) with known effect: Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. The solution is a clear and colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1). Prevention of Venous Thromboembolic Events (VTE) in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Patients undergoing major orthopaedic or abdominal surgery _ The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection. The initial dose should be given _ _ 6 hours following surgical closure provided that haemostasis has been established. Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery. Experience shows that in patients undergoing hip fracture surgery, the risk of VTE cont Baca dokumen lengkapnya